Quality Management System
 |
Unisis received ISO9002: 1994 and ISO13488: 1994 accreditation in 1997 after auditing by TÜV Rheinland. The company subsequently developed an internationally recognized quality management system (QMS) to earn the trust of customers worldwide.
 |
 |
Accreditation was upgraded to ISO9001: 2000 in 2003 and ISO13485: 2003 in 2004. Our internal QMS was also made more stringent as appropriate for a medical device manufacturer.
We pledge to continue the uncompromising pursuit of excellence in response to customer demand for quality. Our confidence in that quest is based on the satisfaction, evaluation, and trust of our clients.
| 1989/10: | Obtained importing and marketing license (BBY6379) |
| 1994/02: | Obtained license for marketing of medical devices (11BZ0588 for the Koshigaya factory) |
| 1995/11: | Obtained Japanese accreditation in Good Maufacturing Practices (GMP). |
| 1996/09: | US Food and Drug Administration registration (No. 9014974/USA) |
| 1997/06: | Obtained accreditation of ISO9002/ISO13483 audited by TÜV Rheinland |
| 1999/01: | Obtained license for manufacturing veterinary appliances (16 veterinary manufacturer No.344 for Koshigaya factory). |
| 2003/06: | Obtained accreditation of ISO9002/ISO13483 audited by TÜV Rheinland |
| 2004/01: | Obtained license for marketing of medical devices (11BZ6041 for Saitama Plant) Obtained license for manufacturing veterinary appliances (16 veterinary manufacturer No. 457 for Saitama factory). |
| 2004/07: | Obtained accreditation of ISO9001/ISO13485 audited by TÜV Rheinland |
| 2005/12: | Obtained CE marking audited by TÜV Rheinland |
